US20030125758A1 - Debulking catheters and methods - Google Patents

Abstract

A method of removing material from a blood flow lumen generally includes providing a device having a cutting element and an opening, advancing the device through the blood flow lumen to a site where material is to be removed, forcing the opening toward a wall of the site where material is to be removed, and moving the cutting element and the opening so that material in the blood flow lumen is cut by the cutting element and directed into the opening for removal as the cutting element and opening are moved through the blood flow lumen. In some embodiments, the device may be deflected or bent to force the opening toward a wall to remove material. The cutting element may be rotatable and may have an axis that is movable, that is not parallel to the longitudinal axis of the device, or both. In some embodiments, the cutting element is movable between retracted and deployed positions for advancing the device to a site for treatment and for removing material, respectively.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS
• The present application is a continuation-in-part of U.S. patent application Ser. No. 10/027,418, filed Dec. 19, 2001, entitled “Debulking Catheter”, which claims the benefit of Provisional Patent Application Serial No. 60/257,704, filed Dec. 20, 2000, entitled “Debulking Catheter” and Provisional Patent Application Serial No. 60/272,273 filed Feb. 27, 2001, entitled “Debulking Catheter”, the complete disclosures of which are incorporated herein by reference.[0001]
• The present application also claims the benefit of Provisional Application No. 60/381,632, filed on May 19, 2002, entitled “Debulking Catheter”, the complete disclosure of which is incorporated herein by reference. The present application is also related to U.S. patent application Ser. No. 09/377,884, filed Aug. 19, 1999, entitled “Apparatus and Methods for Material Capture and Removal” and Ser. No. 09/377,894, filed Aug. 19, 1999, entitled “Apparatus and Methods for Removing Material From a Body Lumen,” the complete disclosures of which are incorporated by reference.[0002]
BACKGROUND OF THE INVENTION
• The present invention relates generally to systems and methods for debulking body lumens. More particularly, the present invention relates to atherectomy catheters for excising atheroma and other materials from blood vessels and from stents.[0003]
• Cardiovascular disease frequently arises from the accumulation of atheromatous material on the inner walls of vascular lumens, particularly arterial lumens of the coronary and other vasculature, resulting in a condition known as atherosclerosis. Atherosclerosis occurs naturally as a result of aging, but may also be aggravated by factors such as diet, hypertension, heredity, vascular injury, and the like. Atheromatous and other vascular deposits restrict blood flow and can cause ischemia which, in acute cases, can result in myocardial infarction. Atheromatous deposits can have widely varying properties, with some deposits being relatively soft and others being fibrous and/or calcified. In the latter case, the deposits are frequently referred to as plaque.[0004]
• One conventional treatment for cardiovascular disease is the use of stents. Endoluminal stents are commonly used to treat obstructed or weakened body lumens, such as blood vessels and other vascular lumens. Once deployed in the blood vessel, the stent can remain in the body lumen where it will maintain the patency of the lumen and/or support the walls of the lumen which surround it. One factor impeding the success of stent technology in endoluminal treatments is the frequent occurrence of in-stent restenosis, characterized by proliferation and migration of smooth muscle cells within and/or adjacent to the implanted stent, causing reclosure or blockage of the body lumen.[0005]
• Atherosclerosis and restenosis can be treated in a variety of ways, including drugs, bypass surgery, and a variety of catheter-based approaches which rely on intravascular debulking or removal of the atheromatous or other material occluding a blood vessel. Of particular interest to the present invention, a variety of methods for cutting or dislodging material and removing such material from the blood vessel have been proposed, generally being referred to as atherectomy procedures. Atherectomy catheters intended to excise material from the blood vessel lumen generally employ a rotatable and/or axially translatable cutting blade which can be advanced into or past the occlusive material in order to cut and separate such material from the blood vessel lumen. In particular, side-cutting atherectomy catheters generally employ a housing having an aperture on one side, a blade which is rotated or translated by the aperture, and a balloon to urge the aperture against the material to be removed.[0006]
• Although atherectomy catheters have proven very successful in treating many types of atherosclerosis and in-stent restenosis, improved atherectomy catheters and methods are continuously being pursued. For example, many currently available side-cutting atherectomy catheters have difficulty in capturing occluding material in the cutting aperture. To facilitate material capture, the cutting aperture is frequently elongated to increase the area into which the material can penetrate. Such elongation typically requires an equivalent lengthening of the cutter housing. Since most cutter housings are rigid, such lengthening makes it more difficult to introduce the distal end of the catheter through tortuous regions of the vasculature.[0007]
• Another shortcoming of many currently available atherectomy catheters is that they typically require a balloon positioned opposite the cutting window to urge the cutting window into contact with occluding material. Such balloons, however, unduly increase the size of the distal portion of the catheter. Even with the balloon, the amount of material that can be removed by conventional atherectomy catheters is limited by the size of the cutting window. Other disadvantages of some catheters include cutting elements with less than ideal hardness, inadequate storage space within the catheter for containing removed material, sub-optimal guide wire lumens, and/or the like.[0008]
• For these reasons, it would be advantageous to have atherectomy catheters, and methods for their use, which could access small, tortuous regions of the vasculature and remove atheromatous and other occluding materials from within blood vessels and stents in a controlled fashion. In particular, it would be desirable to have atherectomy catheters and methods which could facilitate capturing and invagination of atheromatous materials. Ideally, such catheters and methods would be adaptable for use in a variety of body lumens, including but not limited to coronary and other arteries. At least some of these objectives will be met by the present invention.[0009]
BRIEF SUMMARY OF THE INVENTION
• The present invention provides catheters and methods for removing material from (or “debulking”) a body lumen. Catheters of the present invention may be used in a variety of body lumens, including but not limited to intravascular lumens such as coronary arteries. Typically, debulking catheters are used to remove occlusive material, such as arteriosclerotic plaque, from vascular lumens, but they may alternatively be used to remove other materials. Generally, debulking catheters include a proximal portion, a distal portion having an opening (or “window”), and a Cutting element (or “tissue debulking assembly”) which may be exposed through the opening to contact material in a body lumen. The catheter debulks a body lumen when it is moved while the cutting element is in contact with the material in the lumen.[0010]
• In one aspect of the present invention, a method of removing material from a blood flow lumen comprises: providing a device having a cutting element and an opening; advancing the device through the blood flow lumen to a site where material is to be removed; forcing the opening toward a wall of the site where material is to be removed; and moving the cutting element and the opening after the forcing step so that material in the blood flow lumen is cut by the cutting element and directed into the opening for removal as the cutting element and opening are moved through the blood flow lumen. Optionally, the moving step may be carried out with the cutting element and the opening moving together in unison through the blood flow lumen.[0011]
• In some embodiments, the forcing step is carried out by bending the device so that the opening is forced against the wall of the site. Also in some embodiments, the providing step is carried out with the cutting element being rotatable, with the moving step being carried out with the cutting element rotating when severing the material. When the cutting element is rotatable, the providing step may be carried out with the device having a longitudinal axis, and with the moving step being carried out with the cutting element rotating around an axis which is not parallel to the longitudinal axis of the device. In some embodiments, the providing step is carried out with the cutting element having an axis of rotation which is movable relative to a longitudinal axis of the device.[0012]
• In some embodiments, the moving step is carried out with the cutting element cutting a continuous piece of material. Optionally, in such embodiments, the providing step may be carried out with the opening being on a side of the device; the forcing step may be carried out to force the side against the blood flow lumen; and the moving step may be carried out with the cutting element extending out of the opening, the cutting element directing the continuous piece of material into the opening. In some embodiments, the moving step is carried out by moving the cutting element and window in a distal direction, with the cut material being stored in the device at a location distal to the cutting element. Also in some embodiments, the providing step is carried out with the cutting element being movable relative to the opening.[0013]
• In still other embodiments, the providing step is carried out with the cutting element being movable between a deployed position and a retracted position, the cutting element extending out of the opening when in the deployed position and being contained within the opening when in the retracted position. In such embodiments, the advancing step is typically carried out with the cutting element in the retracted position and the moving step is carried out with the cutting element being in the deployed position. For example, the providing step may be carried out with the cutting element extending beyond the opening a distance of about 0.025 mm to about 0.64 mm. Generally, the providing step may be carried out with the opening being positioned along a side of the device.[0014]
• For a further understanding of the nature and advantages of the invention, reference should be made to the following description taken in conjunction with the accompanying drawings.[0015]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of a debulking catheter of the present invention;[0016]
• FIG. 1A is a side view of a portion of a debulking catheter as in FIG. 1, where the body has a rigid distal portion with a bend, according to one embodiment of the present invention;[0017]
• FIG. 2 is an exploded view of an exemplary distal portion of the debulking catheter of the present invention;[0018]
• FIG. 3A is an end view of the distal portion of the debulking catheter of FIG. 1 in which the cutter is in a closed position in the catheter body;[0019]
• FIG. 3B is a sectional view along Line A-A of FIG. 3A;[0020]
• FIGS. 3C and 3D are views of the distal portion of a debulking catheter, where the distal portion has a locking shuttle mechanism;[0021]
• FIG. 4A is an end view of the distal portion of the debulking catheter of FIG. 1 in which the cutter is in an open position outside of the cutting window;[0022]
• FIG. 4B is a sectional view along Line A-A of FIG. 4A;[0023]
• FIGS. 4C and 4D are views of the distal portion of a debulking catheter, where the distal portion has a locking shuttle mechanism;[0024]
• FIG. 5A is an end view of the distal portion of the debulking catheter of FIG. 1 in which the cutter is in a packing position within a tip of the catheter;[0025]
• FIG. 5B is a sectional view along Line A-A of FIG. 5A;[0026]
• FIGS.[0027]6 to8 illustrate a monorail delivery system of the present invention;
• FIG. 9A is a perspective view of a cutter of the present invention;[0028]
• FIG. 9B is an end view of the cutter of FIG. 9A;[0029]
• FIG. 9C is a sectional view of the cutter along Line A-A of the cutter of FIGS. 9A and 9B;[0030]
• FIG. 10A is a perspective view of a in-stent restenosis cutter of the present invention;[0031]
• FIG. 10B is an end view of the cutter of FIG. 10A;[0032]
• FIG. 10C is a sectional view of the cutter along Line B-B of the cutter of FIGS. 10A and 10B;[0033]
• FIG. 11A is a perspective view of another in-stent restenosis cutter of the present invention;[0034]
• FIG. 11B is an end view of the cutter of FIG. 11A;[0035]
• FIG. 11C is a sectional view of the cutter along Line C-C of the cutter of FIGS. 11A and 11B;[0036]
• FIG. 11D is a side view of another embodiment of a cutter, shown partially within a catheter body;[0037]
• FIG. 12 illustrates a proximal handle and cutter driver of the present invention;[0038]
• FIG. 13 illustrates a cutter driver with a handle cover removed;[0039]
• FIGS.[0040]14 to16 illustrate three positions of the lever for controlling the cutter;
• FIG. 17 is a simplified flow chart illustrating a method of the present invention;[0041]
• FIGS. 18 and 19 illustrate a method of the present invention;[0042]
• FIG. 20 schematically illustrates another method of the present invention; and[0043]
• FIG. 21 illustrates a kit of the present invention.[0044]
DETAILED DESCRIPTION OF THE INVENTION
• The catheters and methods of the present invention are designed to debulk atheroma and other occlusive material from diseased body lumens, and in particular coronary arteries, de novo lesions, and in-stent restenosis lesions. The catheters and methods, however, are also suitable for treating stenoses of body lumens and other hype plastic and neoplastic conditions in other body lumens, such as the ureter, the biliary duct, respiratory passages, the pancreatic duct, the lymphatic duct, and the like. Neoplastic cell growth will often occur as a result of a tumor surrounding and intruding into a body lumen. Debulking of such material can thus be beneficial to maintain patency of the body lumen. While the remaining discussion is directed at debulking and passing through atheromatous or thrombotic occlusive material in a corollary artery, it will be appreciated that the systems and methods of the present invention can be used to remove and/or pass through a variety of occlusive, stenotic, or hyperplastic material in a variety of body lumens.[0045]
• Apparatus according to the present invention will generally comprise catheters having catheter bodies adapted for intraluminal introduction to the target body lumen. The dimensions and other physical characteristics of the catheter bodies will vary significantly depending on the body lumen which is to be accessed. In the exemplary case of atherectomy catheters intended for intravascular introduction, the proximal portions of the catheter bodies will typically be very flexible and suitable for introduction over a guidewire to a target site within the vasculature. In particular, catheters can be intended for “over-the-wire” introduction when a guidewire channel extends fully through the catheter body or for “rapid exchange” introduction where the guidewire channel extends only through a distal portion of the catheter body. In other cases, it may be possible to provide a fixed or integral coil tip or guidewire tip on the distal portion of the catheter or even dispense with the guidewire entirely. For convenience of illustration, guidewires will not be shown in all embodiments, but it should be appreciated that they can be incorporated into any of these embodiments.[0046]
• Catheter bodies intended for intravascular introduction will typically have a length in the range from 50 cm to 200 cm and an outer diameter in the range from 1 French to 12 French (0.33 mm: 1 French), usually from 3 French to 9 French. In the case of coronary catheters, the length is typically in the range from 125 cm to 200 cm, the diameter is preferably below 8 French, more preferably below 7 French, and most preferably in the range from 2 French to 7 French. Catheter bodies will typically be composed of an organic polymer which is fabricated by conventional extrusion techniques. Suitable polymers include polyvinylchloride, polyurethanes, polyesters, polytetrafluoroethylenes (PTFE), silicone rubbers, natural rubbers, and the like. Optionally, the catheter body may be reinforced with braid, helical wires, coils, axial filaments, or the like, in order to increase rotational strength, column strength, toughness, pushability, and the like. Suitable catheter bodies may be formed by extrusion, with one or more channels being provided when desired. The catheter diameter can be modified by heat expansion and shrinkage using conventional techniques. The resulting catheters will thus be suitable for introduction to the vascular system, often the coronary arteries, by conventional techniques.[0047]
• The distal portion of the catheters of the present invention may have a wide variety of forms and structures. In many embodiments, a distal portion of the catheter is more rigid than a proximal portion, but in other embodiments the distal portion may be equally as flexible as the proximal portion. One aspect of the present invention provides catheters having a distal portion with a reduced rigid length. The reduced rigid length can allow the catheters to access and treat tortuous vessels and small diameter body lumens. In most embodiments a rigid distal portion or housing of the catheter body will have a diameter that generally matches the proximal portion of the catheter body, however, in other embodiments, the distal portion may be larger or smaller than the flexible portion of the catheter.[0048]
• A rigid distal portion of a catheter body can be formed from materials which are rigid or which have very low flexibilities, such as metals, hard plastics, composite materials, NiTi, steel with a coating such as titanium nitride, tantalum, ME-92®, diamonds, or the like. Most usually, the distal end of the catheter body will be formed from stainless steel or platinum/iridium. The length of the rigid distal portion may vary widely, typically being in the range from 5 mm to 35 mm, more usually from 10 mm to 25 mm, and preferably between 6 mm and 8 mm. In contrast, conventional catheters typically have rigid lengths of approximately 16 mm.[0049]
• The side opening windows of the present invention will typically have a length of approximately 2 mm. In other embodiments, however, the side opening cutting window can be larger or smaller, but should be large enough to allow the cutter to protrude a predetermined distance that is sufficient to debulk material from the body lumen.[0050]
• The catheters of the present invention can include a flexible atraumatic distal tip coupled to the rigid distal portion of the catheter. For example, an integrated distal tip can increase the safety of the catheter by eliminating the joint between the distal tip and the catheter body. The integral tip can provide a smoother inner diameter for ease of tissue movement into a collection chamber in the tip. During manufacturing, the transition from the housing to the flexible distal tip can be finished with a polymer laminate over the material housing. No weld, crimp, or screw joint is usually required.[0051]
• The atraumatic distal tip permits advancing the catheter distally through the blood vessel or other body lumen while reducing any damage caused to the body lumen by the catheter. Typically, the distal tip will have a guidewire channel to permit the catheter to be guided to the target lesion over a guidewire. In some exemplary configurations, the atraumatic distal tip comprises a coil. In some configurations the distal tip has a rounded, blunt distal end. The catheter body can be tubular and have a forward-facing circular aperture which communicates with the atraumatic tip. A collection chamber can be housed within the distal tip to store material removed from the body lumen. The combination of the rigid distal end and the flexible distal tip is approximately 30 mm.[0052]
• A rotatable cutter or other tissue debulking assembly may be disposed in the distal portion of the catheter to sever material which is adjacent to or received within the cutting window. In an exemplary embodiment, the cutter is movably disposed in the distal portion of the catheter body and movable across a side opening window. A straight or serrated cutting blade or other element can be formed integrally along a distal or proximal edge of the cutting window to assist in severing material from the body lumen. In one particular embodiment, the cutter has a diameter of approximately 1.14 mm. It should be appreciated however, that the diameter of the cutter will depend primarily on the diameter of the distal portion of the catheter body.[0053]
• In exemplary embodiments, activation of an input device can deflect a distal portion of the catheter relative to the proximal portion of the catheter. Angular deflection of the distal portion may serve one or more purposes in various embodiments. Generally, for example, deflection of the distal portion increases the effective “diameter” of the catheter and causes the debulking assembly to be urged against material in a lumen, such as arteriosclerotic plaque. In other embodiments, deflection of the distal portion may act to expose a debulking assembly through a window for contacting material in a lumen. In some embodiments, for example, activation of the input device moves the debulking assembly over a ramp or cam so that a portion of the rigid distal portion and flexible tip are caused to drop out of the path of the debulking assembly so as to expose the debulking assembly through the window. In some embodiments, deflection may both urge a portion of the catheter into material in a lumen and expose a tissue debulking assembly.[0054]
• Some embodiments further help to urge the debulking assembly into contact with target tissue by including a proximal portion of the catheter body having a rigid, shaped or deformable portion. For example, some embodiments include a proximal portion with a bend that urges the debulking assembly toward a side of the lumen to be debulked. In other embodiments, one side of the proximal portion is less rigid than the other side. Thus, when tension is placed on the catheter in a proximal direction (as when pulling the debulking assembly proximally for use), one side of the proximal portion collapses more than the other, causing the catheter body to bend and the debulking assembly to move toward a side of the lumen to be debulked.[0055]
• In exemplary embodiments, the debulking assembly comprises a rotatable cutter that is movable outside the window. By moving the cutter outside of the cutting window beyond an outer diameter of the distal portion of the catheter, the cutter is able to contact and sever material that does not invaginate the cutting window. In a specific configuration, the rotating cutter can be moved over the cam within the rigid, or distal, portion of the catheter body so that the cutting edge is moved out of the window. Moving the rotating cutter outside of the Cutting window and advancing the entire catheter body distally, a large amount of occlusive material can be removed. Consequently, the amount of material that can be removed is not limited by the size of the cutting window.[0056]
• As will be described in detail below, in some situations it is preferable to provide a serrated cutting edge, while in other situations it may be preferable to provide a smooth cutting edge. Optionally, the cutting edge of either or both the blades may be hardened, e.g., by application of a coating. A preferred coating material is a chromium based material, available from ME-92, Inc., which may be applied according to manufacturer's instructions. In some embodiments, the cutter includes a tungsten carbide cutting edge. Other rotatable and axially movable cutting blades are described in U.S. Pat. Nos. 5,674,232; 5,242,460; 5,312,425; 5,431,673; and 4,771,774, the full disclosures of which are incorporated herein by reference. In some embodiments, a rotatable cutter includes a beveled edge for removal of material from a body lumen while preventing injury to the lumen. In still other embodiments, a tissue debulking assembly may include alternative or additional features for debulking a lumen. For example, the debulking assembly may include, but is not limited to, a radio frequency device, an abrasion device, a laser cutter and/or the like.[0057]
• The catheters of the present invention may include a monorail delivery system to assist in positioning the cutter at the target site. For example, the tip of the catheter can include lumen(s) that are sized to receive a conventional guidewire (typically 0.014″ diameter) or any other suitable guidewire (e.g., having diameters between 0.018″ and 0.032″) and the flexible proximal portion of the catheter body can include a short lumen (e.g., about 12 centimeters in length). Such a configuration moves the guidewire out of the rigid portion so as to not interfere with the debulking assembly.[0058]
• In other embodiments, however, the guidewire lumen may be disposed within or outside the flexible proximal portion of the catheter body and run a longer or shorter length, and in fact may run the entire length of the flexible portion of the catheter body. The guidewire can be disposed within lumen on the flexible portion of the catheter body and exit the lumen at a point proximal to the rigid portion of the catheter. The guidewire can then enter a proximal opening in the tip lumen and exit a distal opening in the tip lumen. In some embodiments the catheter has a distal guidewire lumen on its flexible distal tip and a proximal guidewire lumen on its flexible body. For example, in some embodiments the distal lumen may have a length of between about 2.0 cm and about 3.0 cm and the proximal lumen may have a length of between about 10 cm and about 14 cm. In yet further embodiments, a distal tip guidewire lumen may be configured to telescope within a proximal guidewire lumen, or vice versa. A telescoping guidewire lumen may enhance performance of the catheter by preventing a guidewire from being exposed within a body lumen.[0059]
• The present invention may optionally employ any of a wide variety of conventional radiopaque markers, imaging devices, and/or transducers. In exemplary embodiments, the catheters of the present invention can include a radiopaque distal portion and/or radiopaque markers disposed on a distal portion of the catheter body, such as proximal and distal of the cutting window, on the cam or ramp, so as to allow the user to track the position of the cutter, or the like. The catheters of the present invention will also be particularly useful with ultrasonic transducers, such as an IVUS, of a type which may be deployed linearly within the catheter body or circumferentially on the debulking assembly. Linear deployment will allow viewing along a discrete length of the catheter axis, preferably adjacent to the cutting point, usually over a length in the range from 1 mm to 30 mm, preferably 2 mm to 10 mm. Circumferentially deployed phased arrays may subtend a viewing arc in the range from 5° to 360°, usually from 180° to 360°. For imaging transducers located on cutting blades within a housing or second cutting element, the field of imaging will generally be limited by the dimensions of the aperture. In some cases, however, it might be possible to fabricate all or a portion of the cutter blade/housing out of an ultrasonically translucent material. A more complete description of suitable imaging catheters are described more filly in U.S. patent application Ser. No. 09/378,224, filed Aug. 19, 1999, and entitled “Atherectomy Catheter with Aligned Imager,” now U.S. Pat. No., 6,299,622 B1, the complete disclosure of which is incorporated herein by reference. In addition to ultrasonic array transducers, the imaging devices of the present invention may comprise optical coherence tomography devices, such as described in U.S. Pat. No. 5,491,524, the full disclosure of which is incorporated herein by reference, as well as Huang et al. (1991) Science 254:1178-1181; Brezinski et al. (1997) Heart 77:397-403; and Brezinski et al (1996) Circulation 93:1206-1213. In some instances, the present invention may also provide optical imaging using optical wave guides and the like.[0060]
• Referring now to FIG. 1, a[0061]catheter20 constructed in accordance with principles of the present invention comprises acatheter body22 having aproximal portion24 and adistal portion26.Proximal portion24 can be coupled todistal portion26 with aconnection assembly27 to allow pivoting or deflection ofdistal portion26 relative toproximal portion24. A proximal end of thecatheter body22 can have ahandle40 for manipulation by a user, a lumen for connection to an aspiration or fluid delivery channel, or the like.
• A debulking assembly, such as a[0062]cutter28, abrasive member, or the like, is disposed within alumen30 of thecatheter body22. Thecutter28 is typically rotatable within thedistal portion26 about an axis that is parallel to the longitudinal axis of thedistal portion26 ofcatheter20 and axially movable along the longitudinal axis. Thecutter28 can access target tissue through aside opening window32 which is typically large enough to allow thecutter28 to protrude through and move out of the window32 a predetermined distance. The cutter is coupled to acutter driver34 through acoiled drive shaft36. Actuation of a movable actuator orother input device38 can activate thedrive shaft36 and cutter,move cutter28 longitudinally over a cam so as to deflect the distal portion and move thecutter28 out of cuttingwindow32. Cramming of thecutter28 can cause thedistal portion26 to pivot or deflect relative to theproximal portion24 so as to deflect and urge the cutter into the tissue in the body lumen.
• In some embodiments, the[0063]distal portion26 of the catheter may be moved to an angled or offset configuration from the longitudinal axis of theproximal portion24 of the catheter and thecutter28. In some embodiments, thecutter28 can also be deflected off of the axis of the proximal and/or distal portion of the catheter. Moving thedistal portion26 to an angled/offset position may cause a portion of the catheter to urge against a target tissue, may expose thecutter28 through thewindow32 or both, in various embodiments.
• In[0064]catheters20 of the present invention,proximal portion24 is typically relatively flexible anddistal portion26 is typically relatively rigid. Additionally, many embodiments include a flexibledistal tip42. The flexibleproximal portion24 of the catheter is typically a torque shaft and thedistal portion26 is typically a rigid tubing. Thetorque shaft24 facilitates transportation of thecatheter body22 andcutter28 to the diseased site. The proximal end of thetorque shaft24 is coupled to aproximal handle40 and the distal end of the torque shaft is attached to the distal,rigid portion26 of the catheter through theconnection assembly27. Thedrive shaft36 is movably positioned within thetorque shaft24 so as to rotate and axially move within thetorque shaft24. Thedrive shaft36 andtorque shaft24 are sized to allow relative movement of each shaft without interfering with the movement of the other shaft. The catheter body will have the pushability and torqueability such that torquing and pushing of the proximal end will translate motion to thedistal portion26 of thecatheter body22.
• Referring now to FIG. 1A, a[0065]catheter20 as in FIG. 1 may have a flexibleproximal portion24 which additionally includes urging means25. As shown in FIG. 1A, urging means25 may comprise a rigid bent or curved shape towards the distal end ofproximal portion24, which may help urge thecutter28 or other debulking apparatus toward a wall of a body lumen to enhance treatment. Such a rigid bend increases the working range of the catheter by allowing the cutter to be urged into a lumen wall across a wider diameter.
• In other embodiments, urging means[0066]25 may take many other suitable forms. For example, a similar result to the rigid bend may be achieved by including a rigid distal portion that is not permanently bent but that is more rigid on one side than on the opposite side ofcatheter body22. Thus, when proximal tension is applied to theproximal portion24, as when proximal force is applied to the debulking apparatus to expose thecutter28 through thewindow32, the urging means25 (i.e., the rigid distal portion of proximal portion24) will cause thecatheter body22 to bend toward the less rigid side. The less rigid side will typically be the same side as thewindow32, so that thewindow32 and/or thecutter28 will be urged against a wall of a body lumen by the bend. In still other embodiments, a shaped element may be introduced into catheter body to act as urging means25. Any suitable urging means is contemplated.
• FIG. 2 illustrates an exploded view of a distal end of the catheter. In such embodiments, the catheter[0067]10 includes aconnection assembly27, arigid housing26, adistal tip42 that at least partially defines acollection chamber53 for storing the severed atheromatous material, and a lumen that can receive the guidewire. Thedistal tip42 can have adistal opening43 that is sized to allow an imaging guidewire or conventional guidewire (not shown) to be advanced distally through the tip. In some embodiments, thedistal tip42 may also include a distal guidewire lumen (not shown) for allowing passage of a guidewire. For example, some embodiments may include a distal guidewire lumen having a length of between about 1.0 cm and about 5.0 cm, and preferably between about 2.0 cm and about 3.0 cm. Such a distal guidewire lumen may be used alone or in conjunction with a proximal guidewire lumen located on another, more proximal, portion of thecatheter20.
• In embodiments including a distal guidewire lumen and a proximal guidewire lumen, the distal lumen may be configured to partially telescope within a portion of the proximal guidewire lumen, or vice versa. Such telescoping lumens may be used in embodiments where the[0068]distal portion26 ofcatheter body22 is movable relative to theproximal portion24. A telescoping lumen may enhance performance of thecatheter20 by allowing a guidewire to be maintained largely within a lumen and to not be exposed within the body lumen being treated. Telescoping lumens may have any suitable diameters and configurations to allow for sliding or otherwise fitting of one lumen within another.
• A ramp or[0069]cam44 can at least partially fit within thedistal portion26. As will be described in detail below, in many embodiments proximal movement of thecutter28 over theramp44, causes the deflection of thedistal housing26 and guidescutter28 out of cuttingwindow32. (In other embodiments, a ramp may be used to deflect the distal portion without extending the cutter out of the window.) Attached to theramp44 is ahousing adaptor46 that can connect one ormore articulation member48 to the distal tip to create an axis of rotation of thedistal portion26. Thehousing adaptor46 andarticulation member48 allow the distal end of the catheter to pivot and bias against the body lumen. In the illustrated embodiment there are only onehousing adaptor46 and onearticulation member48, but it should be appreciated that the catheters of the present invention can include, two, three, or more joints (e.g., axis of rotation), if desired. Moreover, the axes of rotation can be parallel or non-parallel with each other.
• The catheter can also include a[0070]shaft adaptor50 andcollar52 to couplearticulation member48 to thetorque shaft22.Shaft adaptor50 can connect the housing to the torque shaft andcollar52 can be placed over a proximal end of the shaft adaptor and crimped for a secure attachment. It should be appreciated by one of ordinary skill in the art that while one exemplary catheter of the present invention has the above components that other catheters of the present invention may not include more or fewer of the components described above. For example, some components can be made integral with other components and some components may be left out entirely. Thus, instead of having aseparate ramp44, the ramp may be integrated with the distal tip to direct the cutter out of the cutting window.
• As shown in FIGS.[0071]3-5, thecutters28 of the present invention will generally be movable between two or more positions. During advancement through the body lumen, the cutter will generally be in a neutral position (FIGS. 3A and 3B) in which thecutter28 is distal of cuttingwindow32. In some embodiments, an imaging device (not shown) can be coupled tocutter28 so as to image the body lumen through cuttingwindow32 whencutter28 is in the neutral position. Once thecatheter20 has reached the target site, thecutter28 can be moved to an open position (FIGS. 4A and 4B) in which thecutter28 is moved to a proximal end of the cuttingwindow32 and will extend out of the cutting window32 a distance L₁beyond an outer diameter D of therigid portion26. In most embodiments, in the open position, the cutter will have deflected the distal portion and the cutter's axis of rotation will generally be in line withconnection assembly27 but angled or offset from longitudinal axis of the distal portion of the catheter body.
• Optionally, in some embodiments,[0072]cutter28 can be moved to a packing position, in which the cutter is moved distally, past the neutral position, so as to pack the severed tissue into a distal collection chamber53 (FIGS. 5A and 5B). It should be appreciated however, that while the exemplary embodiment moves the cutter to the above described positions, in other embodiments of the present invention the cutter can be positioned in other relative positions. For example, instead of having the neutral position distal of the cutting window, the neutral position may be proximal of the window, and the open position may be along the distal end of the cutting window, or the like.
• Referring again to FIGS. 4A and 4B, the interaction of the components of the rigid[0073]distal portions26 in one exemplary embodiment of the present invention will be further described. As shown in FIG. 4B, the cuttingwindow32 is typically a cutout opening in thedistal portion26. While the size of the cuttingwindow32 can vary, the cutting window should be long enough to collect tissue and circumferentially wide enough to allow the cutter to move out of the cutting window during cutting, but sized and shaped to not expel emboli into the vasculature. Cams or ramp44 (shown most clearly in FIG. 4B) can be disposed in the distal portion of the catheter body to guide or otherwise pivot thecutter28 out of the cuttingwindow32 as thecutter28 is pulled proximally through tensioning ofdrive shaft36.
• A joint is located proximal to the cutting[0074]window32 to provide a pivot point for cramming of thedistal portion26 relative to theproximal portion24. The bending at a flexible joint49 is caused by the interaction of cams or ramps44 withcutter28 and the tensile force provided throughdrive shaft36. In the exemplary configuration, the joint includes ahousing adaptor46 that is pivotally coupled to the distalrigid portion26. As shown in FIGS. 4A and 4B, the resulting pivoting of the rigiddistal portion26 relative to the proximal portion causes a cramming effect which urges the distal housing against the body lumen wall without the use of urging means (e.g., a balloon) that is positioned opposite of the cutting window. Thus, the overall cross sectional size of the catheter bodies can be reduced to allow the catheter to access lesions in smaller body lumens. In exemplary embodiments, the distal housing can deflect off of the axis of the proximal portion of the catheter typically between 0° degrees and 30° degrees, usually between 5° degrees and 20° degrees, and most preferably between 5° degrees and 10° degrees. The angle of deflection relates directly to the urge. Urge, however, does not necessarily relate to force but more to the overall profile of the catheter. For example, the greater the angle of deflection, the larger the profile and the bigger the lumen that can be treated. The ranges were chosen to allow treatment of vessels ranging from less than 2 mm to greater than 3 mm within the limits of mechanical design of the components. It should be appreciated however, that the angles of deflection will vary depending on the size of the body lumen being treated, the size of the catheter, and the like.
• In some embodiments, the deflection of the[0075]distal portion26 of the catheter urges the cutter into position such that distal advancement of the entire catheter body can move the rotating cutter through the occlusive material. Because the cutter is moved a distance L₁beyond the outer diameter of the distal portion of the catheter and outside of the cutting window, the user does not have to invaginate the tissue into the cutting window. In some embodiments, for example, the cutter can be moved between about 0.025 mm and about 1.016 mm, and preferably between about 0.025 mm and about 0.64 mm, beyond the outer dimension of the distal housing. It should be appreciated that the cutter excursion directly relates to the depth of cut. The higher the cutter moves out of the cutting window the deeper the cut. The ranges are chosen around efficacy without risk of perforation of the body lumen.
• Some embodiments of the catheter include a shuttle mechanism or other similar mechanism for temporarily locking the catheter in a cutting position. FIGS. 3C and 3D illustrate such an embodiment in the neutral, non-cutting position. Such embodiments generally include a[0076]shuttle member45 and ashuttle stop member42. Theshuttle stop member42 is typically disposed at an angle, relative to a longitudinal axis through the catheter. FIGS. 4C and 4D show the same embodiment in the cutting position. When thecutter28 is moved into the cutting position in such embodiments, theshuttle member45 falls into theshuttle stop member42 and thus locks the debulking apparatus in a cutting position. To unlock the debulking apparatus, thecutter28 may be advanced forward, distally, to release theshuttle member45 from theshuttle stop member42.
• Some embodiments including a shuttle mechanism will also include two joints in[0077]catheter body22. Thus,catheter body22 will include aproximal portion26, adistal portion24 and a middle portion. When shuttle mechanism is activated to exposecutter28 throughwindow32, the middle portion may orient itself at an angle, relative to the proximal and distal portions, thus allowing cutter to be urged towards a side of a lumen. Such a two-jointed configuration may provide enhanced performance of thecatheter20 by providing enhanced contact of thecutter28 with material to be debulked from a body lumen.
• Pushing the entire catheter across a lesion removes all or a portion of the lesion from the body lumen. Severed tissue from the lesion is collected by directing it into a[0078]collection chamber53 in the tip via thecutter28. Once the catheter andcutter28 have moved through the lesion, thecutter28 can be advanced distally to a “part off position” in which the cutter is moved back into the cutting window32 (FIG. 3B). The tissue is collected as the severed pieces of tissue are directed into acollection chamber53 via the distal movement ofcutter28 and catheter. Thecollection chamber53 of the tip anddistal portion26 acts as a receptacle for the severed material, to prevent the severed occlusive material from entering the body lumen and possibly causing downstream occlusions. Thecutter28 can interact with the distal edge of the cutting window to part off the tissue and thereafter pack the severed tissue into collection chamber53 (FIG. 3B). In exemplary embodiments, the driver motor can be programmed to stop the rotation of the cutter at the part off position so that thecutter28 can move to a third position (FIG. 5B) and pack the material in the collection chamber in the tip without rotation. Typically, thecollection chamber53 will be large enough to allow multiple cuts to be collected before the device has to be removed from the body lumen. When the collection chamber is full, or at the user's discretion, the device can be removed, emptied and reinserted over the guidewire via a monorail system, as will be described below.
• In various embodiments, enhancements to the[0079]collection chamber53 may be included. For example, in some embodiments thecollection chamber53 may be configured to be partially or completely translucent or radiolucent and a portion of the catheter surrounding or adjacent to thewindow32 will be radiopaque. This combination ofradiolucent collection chamber53 and radiopaque materialadjacent window32 will enhance the ability of a user to determine how full thecollection chamber53 is, because the fullness of the collection chamber will be directly related to the distance thecutter28 can advance forward into thecollection chamber53. By facilitating the assessment of collection chamber filling, these embodiments will reduce the need for manually withdrawing the catheter to examine thecollection chamber53.
• In some embodiments, the[0080]collection chamber53 may connect to the rigid housing by means of interlocking components, which interlock with complementary components on the rigid housing. Such components may resemble a screw-in configuration, for example. Interlocking components will provide a stable connection between thecollection chamber53 and the rigid housing while not increasing the outer diameter of either thechamber53 or the housing. Generally,collection chamber53 may be given any suitable configuration, shape or size. For example,collection chamber53 in FIGS.6-8 has a helical configuration. Alternatively,collection chamber53 may include a series of circular members, straight linear members, one solid cylindrical or cone-shaped member or the like.
• FIGS. 6 through 8 illustrate one exemplary monorail delivery system to assist in positioning the[0081]cutter28 at the target site. For example, tip42 of the catheter can include alumen54 having adistal opening43 and aproximal opening55 that is sized to receive a guidewire, having a diameter of about 0.014 in., about 0.018 in., about 0.032 in. or any other suitable diameter.
• As shown in FIG. 8, the flexible proximal portion of the catheter body may also include a short lumen[0082]56 (e.g., about 12 centimeters in length). In some embodiments, however, theguidewire lumen56 may be disposed within or outside the flexible proximal portion of the catheter body and run a longer or shorter length, and in fact may run the entire length of theflexible portion24 of the catheter body. In use, the guidewire can be disposed withinlumen56 on the flexible portion of the catheter body and exit the lumen at a point proximal to therigid portion26 of the catheter. The guidewire can then re-enter aproximal opening55 in thetip lumen54 and exit throughdistal opening43 in the tip lumen. By moving the guidewire outside of therigid portion26 of the catheter body, the guidewire will be prevented from tangling with thecutter28. Typically,tip lumen54 will be disposed along at bottom surface of the tip and thelumen56 will be disposed along a side of theproximal portion22 of the catheter body so that the guidewire will be in a helical configuration. In various embodiments, thetip lumen54 and theproximal lumen56 can have any suitable combination of lengths. For example, in one embodiment thetip lumen54 may have a length between about 1 cm and about 5 cm, more preferably between about 2 cm and about 3 cm, and the proximal lumen may have a length of between about 8 cm and about 20 cm, more preferably between about 10 cm and about 14 cm.
• Referring now to FIGS. 22A and 22B, some[0083]catheters120 of the present invention include aproximal guidewire lumen126 coupled with the proximal portion of thecatheter body123, and a telescopingdistal guidewire lumen124 coupled with either thedistal tip122, part of the distal portion of the catheter body, or both. Thetelescoping lumen124 will typically be attached to thetip122 or a distal portion, but will also include allunattached portion121, which will not be directly attached to any part of the catheter body. This unattached portion121 (or “free floating lumen”) protects a guidewire from contacting a body lumen in which the device is used and also allows the device to be moved more freely, without bending or kinking the guidewire. Thetelescoping guidewire124 extends within theproximal lumen126 at thedistal opening127 ofproximal lumen126. Again, the telescoping feature allows for movement of the catheter body while preventing or reducing bending of the guidewire. For example, in someembodiments catheter120 allows for deflection ofdistal tip122 and the distal portion of thecatheter120 relative to theproximal portion123, for example by movement about apivot point129. Telescopingdistal lumen124 andproximal lumen126 allow for this movement by allowingdistal lumen124 to telescope withinproximal lumen126. At the same time,distal lumen124 protects a guide wire from exposure to a body lumen and/or bodily fluids.
• Any suitable configurations and sizes of[0084]distal lumen124 andproximal lumen126 are contemplated. For example, in one embodimentdistal lumen124 may telescope withinproximal lumen126 by a distance of approximately 1 cm. Furthermore, atelescoping lumen24 may be longer than distal lumens in other embodiments. For example,telescoping lumen24 may have a length of between about 2 cm and about 10 cm, and preferably between about 5 cm and about 8 cm. As is apparent from the drawing figures, the outer diameter of telescopingdistal lumen124 is configured to fit within the inner diameter ofproximal lumen126. Generally, any combination of sizes, lengths, diameters and shapes ofdistal lumen124 andproximal lumen126 may be used, to allow telescoping of one into another.
• The catheters of the present invention can include radiopaque markers so as to allow the user to track the position of the catheter tinder fluoroscopy. For example, as already described, a point or area around or adjacent to the window may be made radiopaque. In other embodiments, the rigid[0085]distal portion26 can be radiopaque and radiopaque markers can be disposed on the flexible shaft. Typically, themarkers59 will be disposed along the top, proximal to the cutting window, and on the bottom of the catheter to let the user know the position of the cutter and cutting window relative to the target site. If desired, the top and bottom markers can be different shaped so as to inform the user of the relative orientation of the catheter in the body lumen. Because the guidewire will form a helix in its transition fromlumen56 to tiplumen54, the user will be able to view the top and bottomradiopaque markers59 without interference from the guidewire. Some embodiments of the catheter can also include a radiopaque cutter stop61 (FIG. 3B) that is crimped todriveshaft36 proximal of the cutter that moves with the cutter so as to let the user know when the cutter is in the open position.
• FIGS. 9A through 11D show some exemplary embodiments of the[0086]cutter28 of the present invention. Thedistal portion60 of therotatable cutter28 can include aserrated knife edge62 or asmooth knife edge64 and a curved or scoopeddistal surface66. Thedistal portion60 may have any suitable diameter or height. In some embodiments, for example, the diameter across thedistal portion60 may be between about 0.1 cm and about 0.2 cm. Aproximal portion68 of thecutter28 can include achannel70 that can be coupled to thedrive shaft36 that rotates the cutter. As shown in FIGS.10A-10C, some embodiments of the cutters can include a bulge or bump69 that is provided to interact with a stent so as to reduce the interaction of the cutting edge with the stent. In any of the foregoing embodiments, it may be advantageous to construct aserrated knife edge62, asmooth knife edge64, or a scoopeddistal surface66 out of tungsten carbide.
• Another embodiment of a[0087]cutter28 suitable for use in the present invention is shown in side view within a catheter bodydistal portion26 in FIG. 11D. In this embodiment, thecutter28 has abeveled edge64, made of tungsten carbide, stainless steel, titanium or any other suitable material. Thebeveled edge64 is angled inward, toward the axis of rotation (or center) of thecutter28, creating a “negative angle of attack”65 for thecutter28. Such a negative angle of attack may be advantageous in many settings, when one or more layers of material are desired to be debulked from a body lumen without damaging underlying layers of tissue. Occlusive material to be removed from a vessel typically has low compliance and the media of the vessel (ideally to be preserved) has higher compliance. Acutter28 having a negative angle of attack may be employed to efficiently cut through material of low compliance, while not cutting through media of high compliance, by allowing the high-compliance to stretch over the beveled surface ofcutter28.
• FIGS. 12 through 16 illustrate an[0088]exemplary cutter driver34 of the present invention. As shown in FIG. 12 and13,cutter driver34 can act as the handle for the user to manipulate thecatheters20 of the present invention as well as a power source. Typically, thecutter drivers34 of the present invention include a single input device, such as alever38 that controls the major operations of the catheter (e.g., axial movement to cause urging, rotation to cause cutting, and axial movement for packing). As shown in FIGS. 13 and 14,cutter driver34 includes a power source72 (e.g., batteries), amotor74, amicroswitch76 for activatingmotor74, and a connection assembly (not shown) for connecting thedrive shaft36 to thedriver motor74. In some embodiments, the drive motor can rotate driveshaft36 between 1,000 rpm and 10,000 rpm or more, if desired.
• FIGS. 14 through 16 illustrate one exemplary method of[0089]operating cutter driver34. In use, the catheter will be delivered to the target site with cutter driver unattached and the cutter in the neutral position (FIG. 3B). The cutter driver can be attached with theurge lever38 in a neutral position (FIG. 14), which indicates that the cutter is closed, but not in a15 packing position. The user can then move the catheter (and cutter driver unit, if desired) to position thedistal portion26 of the catheter adjacent the target tissue. As shown in FIG. 15, to activate the rotation of the cutter, theurge lever38 can be moved proximally from the neutral position to move the cutter proximally and out of cutting window32 (FIG. 4B) and simultaneously depressingmicroswitch76 to activatemotor74. At the end of the cutting procedure, as shown in FIG. 16, the user can pushurge lever38 completely forward to a distal position to push the cutter into a packing position (FIG. 5B). After the urge lever passes the middle of the travel, themicroswitch76 can be released so as to deactivate the cutter before reaching the packing position such that packing can occur without the cutter rotating. It should be appreciated, while the figures illustrate the use of an urge lever or thumb switch as an input device, the present invention can use other type of input devices, such as labeled buttons (e.g., close window, debulk tissue, and pack), or the like.
• Advantageously,[0090]cutter driver34 provides an automatic on/off control of thecutter28 that is keyed to the position of the cutter. Such a configuration frees the user from the complicated task of remembering the sequence of operations to activate and deactivate the rotation and axial movement of the cutter.
• While the[0091]cutter driver34 is illustrated as a disposable battery powered unit, it should be appreciated that in other embodiments, the cutter driver can use other power sources to control the cutter driver. It should further be appreciated that other cutter drivers can be used with the present invention. While not preferred, it is possible to have separate controls to control the axial movement of the cutter and the rotation of the cutter.
• Some exemplary methods of the present invention will now be described. One method of the present invention comprises delivering a catheter to a target site in the body lumen. A distal portion of the catheter can be deflected relative to a proximal portion of the catheter to expose a tissue debulking device in the catheter. The body lumen can be debulked with the exposed debulking device. Specifically, as shown schematically in FIG. 17, one specific method comprises advancing a catheter to a target site (Step[0092]100). A cutter can be rotated and moved out of the cutting window (Steps102,104). Preferably, a distal portion of the catheter can be pivoted or deflected so as to position the cutter adjacent the target material. Thereafter, the catheter and the rotating cutter can be moved through the body lumen to remove the target material from the body lumen (Step106).
• As shown in FIGS. 18 and 19, the catheter can be percutaneously advanced through a guide catheter or sheath and over a conventional or imaging guidewire using conventional interventional techniques. The[0093]debulking catheter20 can be advanced over the guidewire and out of the guide catheter to the diseased area. As shown in FIG. 18, thewindow32 will typically be closed (with the cutter orother debulking device28 in a first, distal position). As shown in FIG. 19,catheter20 will typically have at least one hinge or pivot connection to allow pivoting about one or more axes of rotation to enhance the delivery of the catheter into the tortuous anatomy without dislodging the guide catheter or other sheath. The cutter can be positioned proximal of the lesion. Optionally, a transducer, IVUS, or other imaging assembly can be used to verify the position of the debulking catheter.
• Once the position of the catheter is confirmed, the[0094]cutter28 will be retracted proximally and moved out of cuttingwindow32 to its second, exposed position. In some embodiments, movement of the cutter can deflect the distal portion of the catheter to increase the profile of the catheter at the target site. Movement of the cutter is typically caused by proximal movement oflever38 and tensioning ofdrive shaft36. Movement of the lever can be scaled to any desired ratio or a direct 1:1 ratio of movement between the handle and cutter. When the cutter is moved proximally it contacts ramp or cam surfaces so as to guide the cutter tip and at least partially out of the cuttingwindow32. Additionally, as shown byarrow80, the distal portion ofcatheter body26 rotates about the joint49 to provide an urging force for the cutter (and catheter body) to move toward the diseased area.
• Thereafter, as shown by[0095]arrow82 the operator can move theentire catheter body22 through the lesion to dissect the tissue. As thecutter28 andcatheter body22 are advanced distally through the lesion, tissue that is trapped between the cuttingedge52 and the cuttingwindow32 is severed from the body lumen. To part off the tissue, the operator can stop pushing the device distally and the cutter can be advanced distally inside the cutting window by advancing thehandle38. During the distal movement of the cutter, thecutter28 rides back over theramps44 and directs the cutter back inside of the cuttingwindow32. Such movement causes thedistal portion26 of the catheter to move in line with the cutter and proximal portion24 (FIG. 5B). When the cutter has moved to its distal position, the cutter parts off the severed tissue and urges the severed tissue inside of acollection chamber53 in thedistal tip42. Optionally, after thecutter28 has parted off the tissue, thelever38 and thus thenon-rotating cutter38 can be advanced distally to pack the tissue into the collection chamber53 (FIG. 5B). Use of the cutter to pack the severed tissue will allow the operator multiple specimens to be collected prior to removing thecatheter20 from the body lumen. When it is determined that the collection chamber is full, the catheter can be removed from the body lumen and the collection chamber can be emptied.
• In another method of the present invention, as shown in FIG. 20, an input device is disposed in a first position to position a tissue removal element in a neutral position (Step[0096]120). The input device is activated to rotate the tissue removal element and to axially move the tissue removal device to an active position (Step122). The input device can then be activated again to move the tissue removal element to a packing position (Step124). In an exemplary embodiment, the input device is a lever or thumb switch that can be moved to correspond to the movement of a cutting element on the catheter. Thus, as the lever is moved proximally, the cutter is rotated and moved proximally to an open position. When the lever is moved to a distal position, the rotation of the cutter can be stopped and the cutter can be moved distally to pack severed tissue into a collection chamber.
• Referring now to FIG. 21, the present invention will further comprise[0097]kits including catheters200, instructions foruse202, and packages204.Catheters200 will generally be as described above, and the instruction for use (IFU)202 will set forth any of the methods described above.Package204 may be any conventional medical device packaging, including pouches, trays, boxes, tubes, or the like. The instructions foruse202 will usually be printed on a separate piece of paper, but may also be printed in whole or in part on a portion of thepackaging204.
• While all the above is a complete description of the preferred embodiments of the inventions, various alternatives, modifications, and equivalents may be used. For example, while preferred cutters are moved proximally to move the cutter out of the cutting window, alternative embodiments may move the cutter distally to move the cutter out of the cutting window. Additionally, while most embodiments employ a cutter that extends out beyond the outer diameter of the cutting window, it may be possible to incorporate a cutter that stays within the diameter catheter body. Additionally, in some embodiments, the debulking assembly may be exposed through the window without causing a deflection of the distal portion of the catheter. Moreover, instead of having a distal tip that is rotatable relative to the proximal portion of the catheter, the catheter can include a shape memory material such that the catheter forms a jog or a pre-bent shape when it reaches its target area. Although the foregoing invention has been described in detail for purposes of clarity of understanding, it will be obvious that certain modifications may be practiced within the scope of the appended claims.[0098]

Claims (15)

What is claimed is:

1. A method of removing material from a blood flow lumen, the method comprising:

providing a device having a cutting element and an opening;

advancing the device through the blood flow lumen to a site where material is to be removed;

forcing the opening toward a wall of the site where material is to be removed; and

moving the cutting element and the opening after the forcing step so that material in the blood flow lumen is cut by the cutting element and directed into the opening for removal as the cutting element and opening are moved through the blood flow lumen.

2. A method as inclaim 1, wherein the moving step is carried out with the cutting element and the opening moving together in unison through the blood flow lumen.

3. A method as inclaim 1, wherein the forcing step is carried out by bending the device so that the opening is forced against the wall of the site.

4. A method as inclaim 1, wherein the providing step is carried out with the cutting element being rotatable, and wherein the moving step is carried out with the cutting element rotating when severing the material.

5. A method as inclaim 4, wherein the providing step is carried out with the device having including a distal portion having a longitudinal axis, and wherein the moving step is carried out with the cutting element rotating around an axis which is not parallel to the longitudinal axis of the device.

6. A method as inclaim 4, wherein the providing step is carried out with the cutting element having an axis of rotation which is movable relative to a longitudinal axis of the device.

7. A method as inclaim 1, wherein the moving step is carried out with the cutting element cutting a continuous piece of material.

8. A method as inclaim 7, wherein:

the providing step is carried out with the opening being on a side of the device; and

the forcing step being carried out to force the side against the blood flow lumen.

9. A method as inclaim 8, wherein the moving step is carried out with the cutting element extending out of the opening, the cutting element directing the continuous piece of material into the opening.

10. A method as inclaim 1, wherein the moving step is carried out by moving the cutting element and window in a distal direction.

11. A method ofclaim 10 wherein the moving step is carried out with the cut material being stored in the device at a location distal to the cutting element.

12. A method as inclaim 1, wherein the providing step is carried out with the cutting element being movable relative to the opening.

13. A method as inclaim 1, wherein:

the providing step is carried out with the cutting element being movable between a deployed position and a retracted position, the cutting element extending out of the opening when in the deployed position and being contained within the opening when in the retracted position;

the advancing step being carried out with the cutting element in the retracted position; and

the moving step being carried out with the cutting element being in the deployed position.

14. A method as inclaim 13, wherein the providing step is carried out with the cutting element extending beyond the opening a distance of about 0.025 mm to about 0.64 mm.

15. A method as inclaim 1, wherein the providing step is carried out with the opening being positioned along a side of the device.

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